Parliament Question: Revision of Drug Testing Norms by CDSCO

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 5685 TOBE ANSWERED ON27TH MARCH, 2026 REVISION OFDRUG TESTING NORMS BYCDSCO 5685.SHRIVISHALDADAPRAKASHBAPU PATIL: DR. SHRIKANTEKNATH SHINDE: SHRIRAVINDRADATTARAM WAIKAR: SMT. BHARTIPARDHI: SHRISHRIRANG APPACHANDU BARNE: SHRIATULGARG: SHRINARESH GANPATMHASKE: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) whether the Central Drugs Standard Control Organisation (CDSCO) has revised drug testing norms toexpedite approval of pharmaceutical products, if so, the detailsthereof andif not,the reasons therefor; (b) the details of the changes introduced in regulatory procedures, including timelines, documentationandtesting requirementsfor drug approvals; (c) the policy measures undertaken to ensure that fast-track approval mechanisms maintain safety, efficacyandquality standards, if so, the detailsthereofandif not,the reasons therefor; (d) the steps taken or proposed to be taken by the Government to strengthen regulatory oversight, laboratorycapacity andpost-market surveillance of approveddrugs; and (e) the expected impact of these revised norms on improving access to medicines, promoting innovationandstrengthening the pharmaceuticalregulatoryframework inthe Country? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL) (a)to(e): The New Drugs and Clinical Trials Rules, 2019 were amended vide G.S.R. 46(E) dated 20.01.2026 providing system of “prior intimation” instead of obtaining permission from Central Drugs Standard Control Organization (CDSCO) for manufacture ofcertain categoriesof drugs (exceptcertain highrisk categoryof drugs) for analytical andnon- clinical testing. This reform removes the existing requirement of pharmaceutical companies to obtain a test licence for the manufacture of small quantities these dugs intended for examination, research, or analysis purposes. This will reduce drug development timelines, andthere bypromote innovation. Ministry of HealthandFamily WelfareandCDSCO have takenfollowing measures to ease the regulatory landscape and fast-track approval for the manufacturing of drugs in the country; (i) On 25.02.2026, CDSCO has issued a Guidance Document for submission of application for obtaining Manufacturing License by the Applicant based on Dossier based licensing of Drugs. The dossier based approval process promotes the transparency and ensures fairness in the decision making process. The dossier based approachismore efficient thanthe individualevaluationasit streamlines the process andreducesthe needfor redundantassessment. (ii) On 23.02.2026, CDSCO issued a circular to fast-track approvals for new drugs by allowing No-Objection Certificates (NOCs) for laboratory testing to be issued immediately upon receipt of applications a step aimed at reducing delays inthe drug approval process. Under the revised procedure, NoCs for testing new drugs at designated government laboratories shall be granted upfront, instead of waiting for prior scrutiny of detailedtechnicalspecifications. (iii) On 21.01.2026, the Central Government notified the replacement of permission systemwithonlineintimationmechanismforBA/BE(bioequivalence/bioavailability) studies of unapproved drugs for export purpose. It removes the prior permission requirements for carrying out low risk bioavailability/bioequivalence studies for export purposes. By reducing regulatory timelines and procedural requirements, this reform providessignificant benefitstomanufacturers andthe generic pharmaceutical industry. (iv) On 02.01.2026, the Central government released the newIndian Pharmacopoeia (IP) 2026. Several new blood products, vaccines and anti-tuberculosis medications have beenincludedinit. (v) Validity period for Free Sale Certificate issued by CDSCO to exporters, has been made co-terminuswith the validityof Manufacturing Licence. (vi) In order to minimize the requirement of toxicity studies in animals, CDSCO published circular dated 29.07.2024, to accept already generated preclinical toxicity data for review. Further, the requirement of animal toxicity data needed in certain cases shall be determined on the case by case basis depending on the nature of new claims as well as the mechanism of action etc. and non-clinical data already generatedwith the drug inthe approvedclaim. (vii) In order to enable faster disposal of applications and licenses, CDSCO has issued orders for delegation of powers of certain powers under the Drugs and CosmeticsAct, 1940 and rules thereunder to officers of the rank of Joint Drugs Controller (India)andDeputy Drugs Controller (India). (viii) Online National Drugs Licensing System (ONDLS) portal has been developed by Centre for Development of Advanced Computing (CDAC) in coordination with CDSCO, Government of India and State/UT Drugs Regulatory Authorities which is a single window platform for online processing of various applications for manufacturing and sales licences. An online portal, SUGAM labs is in place since September2023 for integrating the drug testing labsof the CDSCO. It automates the entire workflow for testing of Medical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the quality specification and tracing the testing status in the laboratories. In order to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO along with State Drugs Controllers (SDCs) have conducted Risk-Based Inspections of more than 960 premises since December, 2022 and based on findings, more than 860 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses, warning letters have been taken by the State LicensingAuthorities. Further, more than 1100 cough syrup manufacturers and 380 blood centres have been subjected to intense audit in coordination with State authorities. Increased market surveillance sampling of syrup formulations by Central and State drugs regulators has also beendone. To strengthen the drug testing infrastructure and enhance laboratory capacity across the country, Ministry of Health and Family Welfare has implemented a Centrally Sponsored Scheme 'Strengthening of States’ Drug Regulatory System (SSDRS). The scheme envisages upgrading existing State laboratories, setting up of new drug testing laboratories and upgradation of existing State drug control offices in the country. Under the SSDRS Scheme, funds totallingRs. 756 Crore has beenreleased toStates/UTs aspart of the Central Share and 19 New Drug Testing Labs have been constructed and 28 existing labs have been up-graded invariousStates/UTs. For post-market surveillance of approved drugs and medical devices, the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) at Indian Pharmacopoeia Commission (IPC) at Ghaziabad under the Ministry of Health and Family Welfare, Government of India is collecting the adverse events reports related to the medical products from different Adverse Drug Reaction Monitoring Centres of PvPI and other stakeholders across the country. These reports are analysed from time to time and medical products safety related recommendations are sent to CDSCO for taking appropriate regulatoryactions. *******